II 

114TH CONGRESS 

1ST SESSION S. 1101 

To amend the Federal Food, Drug, and Cosmetic Act to provide for the 

regulation of patient records and certain decision support software. 

IN THE SENATE OF THE UNITED STATES 

APRIL 27, 2015 

Mr. BENNET introduced the following bill; which was read twice and referred 

to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

provide for the regulation of patient records and certain 

decision support software. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Medical Electronic 

5 Data Technology Enhancement for Consumers’ Health 

6 Act’’ or the ‘‘MEDTECH Act’’. 

7 SEC. 2. REGULATION OF MEDICAL SOFTWARE. 

8 Section 520 of the Federal Food, Drug, and Cosmetic 

9 Act (21 U.S.C. 360j) is amended by adding at the end 

10 the following: 


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1 ‘‘(o) REGULATION OF MEDICAL AND CERTAIN DECI2 SION SUPPORT SOFTWARE.— 

3 ‘‘(1) EXCLUSIONS FROM THE CATEGORY OF DE4 VICES.—The term ‘device’, as defined in section 

5 201(h), shall not include the following: 

6 ‘‘(A) Software that is intended for admin7 istrative and operational support of a health 

8 care facility or the processing and maintenance 

9 of financial records, appointment schedules, 

10 business analytics, communication, information 

11 about patient populations, and laboratory 

12 workflow processes. 

13 ‘‘(B) Software that is intended for the pur14 pose of maintaining or encouraging a healthy 

15 lifestyle and are unrelated to the diagnosis, 

16 cure, mitigation, prevention, or treatment of a 

17 disease or disorder. 

18 ‘‘(C) Except for software intended to inter19 pret or analyze medical image data for the pur20 pose of diagnosis, cure, mitigation, prevention, 

21 or treatment of a disease or condition, elec22 tronic patient records, to the extent that such 

23 records are intended to transfer, store, convert 

24 formats, or display the equivalent of a paper 


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1 medical chart, which may include patient his2 tory records if— 

3 ‘‘(i) such records were created, stored, 

4 transferred, or reviewed by health care 

5 professionals, or by individuals working 

6 under supervision of such professionals; 

7 and 

8 ‘‘(ii) such records are part of health 

9 information technology that is certified 

10 under section 3001(c)(5) of the Public 

11 Health Service Act as being in compliance 

12 with applicable certification criteria adopt13 ed under subtitle A of title XXX of such 

14 Act. 

15 ‘‘(D) Except for software intended to inter16 pret or analyze clinical laboratory test data, 

17 software that is intended to transfer, store, con18 vert formats, or display— 

19 ‘‘(i) clinical laboratory test report 

20 data, results, or findings prior to analysis 

21 or interpretation by a health care profes22 sional; or 

23 ‘‘(ii) clinical laboratory test report 

24 data, results, or findings, or related patient 


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1 education information with respect to such 

2 data, to a patient. 

3 ‘‘(E) Except for a device accessory and 

4 software that is intended to acquire, process, or 

5 analyze a medical image or a signal from an in 

6 vitro diagnostic device or a pattern or signal 

7 from a signal acquisition system, software 

8 that— 

9 ‘‘(i) is intended to display, analyze, or 

10 print medical information about a patient 

11 or other medical information (such as peer12 reviewed clinical studies and clinical prac13 tice guidelines); 

14 ‘‘(ii) is intended to support or provide 

15 recommendations to a health care profes16 sional about prevention, diagnosis, or 

17 treatment; and 

18 ‘‘(iii) enables the health care profes19 sional to independently review the basis for 

20 each recommendation that the software 

21 presents such that it is not the intent that 

22 the health care professional rely solely on 

23 any specific recommendations or results 

24 provided by such software to make a clin25 ical diagnosis or treatment decision. 


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1 ‘‘(2) MULTIPLE FUNCTIONALITY PRODUCTS.— 

2 In the case of a product with multiple functionality 

3 that contains a software function that is excluded 

4 under paragraph (1) from the definition of a device 

5 under section 201(h) and a function that meets the 

6 definition of device under section 201(h), the Sec7 retary shall not regulate the excluded software func8 tion of the product as a device, but the Secretary 

9 may assess such software function for the purpose of 

10 determining the safety and effectiveness of the de11 vice function of the product. 

12 ‘‘(3) RULES OF CONSTRUCTION.—Nothing in 

13 this subsection shall be construed as limiting the au14 thority of the Secretary to— 

15 ‘‘(A) exercise enforcement discretion as to 

16 any device subject to regulation under this Act; 

17 or 

18 ‘‘(B) regulate software devices used in the 

19 manufacture and transfusion of blood and blood 

20 components to assist in the prevention of dis21 ease in humans.’’. 

22 SEC. 3. QUALITY AND STANDARDS. 

23 The Secretary of Health and Human Services shall 

24 ensure that software described in subparagraphs (C), (D), 

25 and (E) of subsection (o)(1) of section 520 of the Federal 


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1 Food, Drug, and Cosmetic Act (21 U.S.C. 360j) (as 

2 amended by section 3) is consistent with appropriate qual3 ity principles and standards for software development and 

4 validation. 

5 SEC. 4. CLASSIFICATION OF ACCESSORIES. 

6 Subsection 513(b) of the Federal Food, Drug, and 

7 Cosmetic Act (21 U.S.C. 360c(b)) is amended by adding 

8 at the end the following: 

9 ‘‘(9) The Secretary shall classify an accessory 

10 under this section based on the intended use of the 

11 accessory, notwithstanding the classification of any 

12 other device with which such accessory is intended to 

13 be used.’’. 

14 SEC. 5. CONFORMING AMENDMENT. 

15 Section 201(h) of the Federal Food, Drug, and Cos16 metic Act (21 U.S.C. 321(h)) is amended by adding at 

17 the end ‘‘The term ‘device’ does not include medical and 

18 decision support software described in section 520(o).’’. 

Æ 


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